• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of Mar 29, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR558.300]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 558 -- NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

Subpart B - Specific New Animal Drugs for Use in Animal Feeds

Sec. 558.300 Ivermectin.

(a) Specifications. Type A medicated article containing 2.72 grams ivermectin per pound (g/lb).

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.344 of this chapter.

(d) Special considerations. See § 500.25 of this chapter.

(e) Conditions of use in swine. It is used in feed as follows:

Ivermectin in
grams/ton
Combination in grams/ton Indications for use Limitations Sponsor
(1) 1.8Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis)Feed as the only feed for 7 consecutive days to provide 0.1 milligrams per kilograms (mg/kg) of body weight per day. Withdraw 5 days before slaughter000010
(2) 1.8Bacitracin methylenedisalicylate, 10 to 30Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae); lice (Haematopinus suis); and mange mites (Sarcoptes scabieivar. suis); and for increased rate of weight gain and improved feed efficiencyFeed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter000010
(3) 1.8Bacitracin methylenedisalicylate, 250Weaned, growing-finishing swine: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis); and for control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery, but where symptoms have not yet occurred, or following an approved treatment of disease conditionFeed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter000010
(4) 1.8 to 11.8Adult and breeding swine: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis)Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter000010
(5) 1.8 to 11.8Bacitracin methylenedisalicylate, 250Pregnant sows: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis); and for control of clostridial enteritis caused by Clostridium perfringens in suckling pigletsFeed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter. Feed bacitracin methylenedisalicylate Type C medicated feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours000010
(6) 18.2 to 120Adult and breeding swine: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis)Top dress on daily ration for individual treatment for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter000010

[72 FR 37437, July 10, 2007, as amended at 81 FR 17609, Mar. 30, 2016; 81 FR 95005, Dec. 27, 2016; 84 FR 12499, Apr. 2, 2019; 84 FR 39185, Aug. 9, 2019]

-
-